← FDA Drug Approvals (Drugs@FDA)

TEMOZOLOMIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD V · Approved 2024-08-23

Drug application

FDA Application #

ANDA210030

Application type

Abbreviated New Drug Application (Generic)

Brand name

TEMOZOLOMIDE

Generic name

TEMOZOLOMIDE

Active ingredients

TEMOZOLOMIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

HETERO LABS LTD V

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2024-08-23

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown